Freenome won FDA breakthrough device designation for its blood-based SimpleScreen lung cancer screening assay. The designation applies to adults ages 50 to 80 with at least a 20 pack-year smoking history who are not already in guideline-recommended screening. SimpleScreen uses a multiomic approach that combines DNA methylation and proteomics with a machine-learning classifier. Freenome said a positive blood result should be followed by low-dose computed tomography (LDCT), positioning the test as a risk-enrichment layer for imaging. The designation signals a regulatory route that may shorten development timelines toward an FDA review. The company also pointed to a prior milestone for its SimpleScreen colorectal cancer test, which recently received FDA approval and is expected to be marketed by Abbott. For screening developers, breakthrough designation can meaningfully alter clinical planning, study design, and the competitive landscape in early cancer detection.